Assessment of Arthroscopy in Patients Undergoing Wrist Fracture

NCT02911610 | Completed

• 1 other identifier: 16.206_BS
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

The use of arthroscopy with the surgery of wrist fractures has a great health and economic impact (prolongs the time of surgery, requires adequately trained personnel, increases the time and surgical expenses and the risk of complications, however, in return ameliorate the prognosis and improves the functional recovery). There are few clinical trials showing a sufficient level of evidence in comparing the results of the surgical treatment of these fractures with volar plate and added arthroscopy so it is necessary to perform a clinical trial with an appropriate design and a sufficient sample size to elucidate the usefulness of arthroscopy in wrist fractures. Therefore, the investigators want to perform an open and controlled clinical trial to adequately analyze the role of arthroscopy in the surgical treatment of wrist fractures in the investigators hospitals. The main objective of the study is to probe the arthroscopy effectiveness in the functionality of the injured wrist by PRWE (a questionnaire assessing pain and wrist function) between the treatment groups of the trial at 12 months after surgery and for this the investigators plan a phase IV multicenter clinical trial.

Conditions

Wrist Injuries

Outcome Measures

Primary Outcomes (1)

• Patient-rated Wrist Evaluation (PRWE) questionary score

  12 months after intervention

Study Arms (2)

Arthroscopy + volar plate

EXPERIMENTAL

surgery of wrist fractures with volar plate and added arthroscopy

Device: arthroscopy + volar plate

volar plate

OTHER

surgery of wrist fractures with volar plate

Device: Volar plate

Interventions

arthroscopy + volar plate DEVICE

surgery of wrist fractures with volar plate and added arthroscopy

Arthroscopy + volar plate

Volar plate DEVICE

surgery of wrist fractures with volar plate

volar plate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Patients able to read and understand the same consent.
• Patients over 18 years
• Broken wrist surgery with criteria based on the following criteria (must meet all):
• Patients functionally independent, ie, they can make the purchase without help, categorized according Mackenney or patients who require assisted support by crutches / walker for walking.
• Radiographic unacceptable reduction after 1 attempted closed reduction in the ER, defined as:
• dorsal angulation\> 0 °
• ulnar variance\> 3mm postreduction.
• Step articular\> 1mm (20)
• radial inclination \<15 °
• Patients with unstable fracture.

You may not qualify if:

• Type III open fractures of Gustilo and Anderson.
• Bilateral fractures (not acceptable include more than one doll per patient for the analysis of the variables in the study, always choosing the wrist of the dominant hand).
• Fractures associated ipsilateral upper limb affection (except distal ulnar fracture).
• Fracture or serious injury prior ipsilateral wrist.
• Medical criteria that contraindicate surgery.
• Patients with low functional demand, categorized as dependent as Mackenney, ie, they need help to go shopping and do not require assisted support by crutches / walker for walking.
• Patients with tumor lesions secondary processes (eg osteosarcoma, prostate cancer, breast cancer, multiple myeloma), congenital metabolic (eg osteogenesis imperfecta) and others involving themselves poor prognosis associated with disease.
• Women with suspected pregnancy or pregnancy can not participate in this clinical trial because the collection of monitoring data is expected performing radiographic examinations, in case of pregnancy, would be contraindicated.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Wrist Injuries

Interventions

Arthroscopy

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: September 22, 2016
• Study Start: August 29, 2017
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

ES (1)